Cleared Traditional

DM SLEEVE (K021102) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K021102 · Emily Iker M.D., A.P.C. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
34d
Days
Class 2
Risk

K021102 is an FDA 510(k) clearance for the DM SLEEVE. Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Emily Iker M.D., A.P.C. (Washington, US). The FDA issued a Cleared decision on May 8, 2002 after a review of 34 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emily Iker M.D., A.P.C. devices

Submission Details

510(k) Number K021102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2002
Decision Date May 08, 2002
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.